The risk of getting a head injury per kilometre wearing a helmet relative to the same risk without helmet is the most appropriate measure to assess the effectiveness of the bicycle helmet. Due to lack of data on exposure rates, odds ratios of helmeted versus unhelmeted cyclists for head injury and other injuries on hospitalized victims are broadly used in case-control studies. A general necessary and sufficient condition can be formulated rigorously, for which odds ratios indeed equal risk ratios. However, this condition is not met in case-control studies on bicycle helmets. As a consequence, the real risk of cycling with a helmet can be underestimated by these studies and therefore the effectiveness of the bicycle helmet can be overestimated. The central point is that a wrong estimate of the risk for non-head injuries (the controls) paradoxically can lead to an overestimation of the usefulness of the helmet in protecting against head injuries. Three cases could be found in the literature with sufficient data to assess both risk ratios and odds ratios: the Netherlands, Victoria (Australia) and Seattle (U.S.A). In all three cases, the problem of overestimation of the effectiveness of the helmet by using odds ratios did occur. The effect ranges from small (+ 8 % ) to extremely large ( > + 400 %). Contrary to the original claim of these studies, in two out of three cases the risk of getting a head injury proved not to be lower for helmeted cyclists. Moreover, in all three cases the risk of getting a non-head injury proved to be higher for cyclists with a helmet. It must be concluded that any case-control study in which the control is formed by hospitalized bicyclists is unreliable and likely to overestimate the effectiveness of the bicycle helmet. As a direct consequence, also meta-analyses based on these case-control studies overestimate the effectiveness of the bicycle helmet. Claims on the effectiveness of the bicycle helmet can no longer be supported by these kind of studies. This might explain the discrepancy between case-control studies and other studies, such as time-analysis. It is recommended to use other methods to estimate the risk ratio for the bicycle helmet, along the lines described in this article. (Author/publisher)
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